免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
Study Description
Brief Summary:
The aim of this study was to compare the efficacy of a programmed intermittent bolus injection method compared to conventional continuous infusion in the management of epidural analgesia in pediatric patients correctional osteotomy. As a prospective double blinded randomized controlled trial, the investigators compare the quality of pain control after surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Correctional Osteotomy | Device: Programmed intermittent epidural bolus Device: Continuous epidural infusion | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | triple (Participant, Care Provider, investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients |
| Estimated Study Start Date : | January 2020 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: PIEB (Programmed intermittent epidural bolus)
bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection)
|
Device: Programmed intermittent epidural bolus
bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device
Other Name: PIEB
|
|
Active Comparator: CEI (Continuous epidural infusion)
Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device
|
Device: Continuous epidural infusion
Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device
Other Name: standard, CEI
|
Outcome Measures
Primary Outcome Measures :
- Difference in total amount of ropivacaine injected through epidural analgesia [ Time Frame: 6 hours after surgery ]The difference in the amount of ropivacaine injected into epidural space for 6 hours postoperatively
- Difference in total amount of ropivacaine injected through epidural analgesia [ Time Frame: 12 hours after surgery ]The difference in the amount of ropivacaine injected into epidural space for 12 hours postoperatively
- Difference in total amount of ropivacaine injected through epidural analgesia [ Time Frame: 24 hours after surgery ]The difference in the amount of ropivacaine injected into epidural space for 24 hours postoperatively
- Difference in total amount of ropivacaine injected through epidural analgesia [ Time Frame: 36 hours after surgery ]The difference in the amount of ropivacaine injected into epidural space for 36 hours postoperatively
- Difference in total amount of ropivacaine injected through epidural analgesia [ Time Frame: 48 hours after surgery ]The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively
Secondary Outcome Measures :
- The time for the first patient controlled rescue epidural bolus after surgery [ Time Frame: 48 hours after surgery ]
- Number of patient-controlled rescue epidural bolus for 48 hours postoperatively [ Time Frame: 48 hours after surgery ]
- Pain scores for 6 hours after surgery (VAS) [ Time Frame: 6 hours after surgery ]VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
- Pain scores for 12 hours after surgery (VAS) [ Time Frame: 12 hours after surgery ]VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
- Pain scores for 24 hours after surgery (VAS) [ Time Frame: 24 hours after surgery ]VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
- Pain scores for 48 hours after surgery (VAS) [ Time Frame: 48 hours after surgery ]VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
- Pain scores for 6 hours after surgery (r-FLACC) [ Time Frame: 6 hours after surgery ]r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
- Pain scores for 12 hours after surgery (r-FLACC) [ Time Frame: 12 hours after surgery ]r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
- Pain scores for 24 hours after surgery (r-FLACC) [ Time Frame: 24 hours after surgery ]r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
- Pain scores for 48 hours after surgery (r-FLACC) [ Time Frame: 48 hours after surgery ]r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
- Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. [ Time Frame: 48 hours after surgery ]
-% of patients with given intravenous additional narcotic analgesics
- number of administrating intravenous additional narcotic analgesics per patient
- Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. [ Time Frame: 48 hours after surgery ]
-% of patients with given intravenous additional narcotic analgesics
- total additional dose of intravenous narcotic analgesics per patient
- Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. [ Time Frame: 48 hours after surgery ]
-% of patients with given intravenous additional narcotic analgesics
- measurement tool: Electronic Medical Record(including Drug administration history)
- A dull feeling the patient feels [ Time Frame: 6 hours after surgery ]A dull feeling the patient feels : yes or no
- A dull feeling the patient feels [ Time Frame: 12 hours after surgery ]A dull feeling the patient feels : yes or no
- A dull feeling the patient feels [ Time Frame: 24 hours after surgery ]A dull feeling the patient feels : yes or no
- A dull feeling the patient feels [ Time Frame: 48 hours after surgery ]A dull feeling the patient feels : yes or no
Eligibility Criteria
| Ages Eligible for Study: | 4 Years to 13 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 1. Pediatric patients with between 4 and 13 years
- 2. Patients scheduled for correctional osteotomy of the lower extremity
- 3. Pediatric patients whose weight of 40kg of less
Exclusion Criteria:
- 1. Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
- 2. Patients with symptoms/signs of elevated intracranial pressure with or without a history of elevated intracranial pressure
- 3. If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)
Contacts and Locations
Contacts
| Contact: Yong Seon Choi, MD., PhD. | 82-2-2228-2412 | YSCHOI@yuhs.ac |
Locations
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine | |
| Seoul, Korea, Republic of, 03722 | |
| Contact: Yong Seon Choi, MD, Ph.D 82-2-2228-2412 yschoi@yush.ac | |
Sponsors and Collaborators
Yonsei University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||
| First Posted Date ICMJE | July 8, 2019 | ||||
| Last Update Posted Date | December 12, 2019 | ||||
| Estimated Study Start Date ICMJE | January 2020 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients | ||||
| Official Title ICMJE | The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients | ||||
| Brief Summary | The aim of this study was to compare the efficacy of a programmed intermittent bolus injection method compared to conventional continuous infusion in the management of epidural analgesia in pediatric patients correctional osteotomy. As a prospective double blinded randomized controlled trial, the investigators compare the quality of pain control after surgery. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: triple (Participant, Care Provider, investigator) Primary Purpose: Supportive Care
|
||||
| Condition ICMJE | Correctional Osteotomy | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
60 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 2021 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 4 Years to 13 Years (Child) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04010032 | ||||
| Other Study ID Numbers ICMJE | 4-2019-0418 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Yonsei University | ||||
| Study Sponsor ICMJE | Yonsei University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Yonsei University | ||||
| Verification Date | December 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
